Brand Name

Motegrity

Generic Name
Prucalopride
View Brand Information
FDA approval date: December 14, 2018
Classification: Serotonin-4 Receptor Agonist
Form: Tablet

What is Motegrity (Prucalopride)?

For many people, chronic constipation isn’t just an inconvenience, it can be a daily struggle that affects comfort, mood, and quality of life. When lifestyle changes and over-the-counter remedies don’t provide enough relief, prescription options like Motegrity (prucalopride) can make a meaningful difference. 

Motegrity is a prescription medication used to treat chronic idiopathic constipation (CIC) in adults. “Idiopathic” means the constipation has no identifiable underlying cause. Motegrity belongs to a class of drugs known as selective serotonin type 4 (5-HT4) receptor agonists, which work by stimulating natural bowel movement activity. 

Approved by the U.S. Food and Drug Administration (FDA) in 2018, Motegrity represents a newer, targeted approach to treating chronic constipation compared to older stimulant laxatives. It’s designed for people who have not found consistent relief from diet, hydration, or other medications. 

What does Motegrity do? 

Motegrity helps increase the frequency and predictability of bowel movements in adults with chronic idiopathic constipation. People with CIC often experience fewer than three bowel movements per week, accompanied by straining, bloating, and discomfort. 

By improving bowel motility, the natural contractions of the colon, Motegrity allows stool to move through the digestive tract more efficiently. Patients taking Motegrity typically experience: 

  • More regular bowel movements 
     
  • Less abdominal discomfort and bloating 
     
  • A greater sense of complete evacuation after using the bathroom 

In clinical studies, significantly more patients achieved three or more spontaneous bowel movements per week compared with those taking a placebo (FDA, 2018). These improvements often lead to better overall comfort and day-to-day functioning. 

Motegrity is not a quick-acting laxative. Instead, it supports the body’s natural rhythm, making it a suitable long-term therapy for those with persistent constipation. 

How does Motegrity work? 

Motegrity contains prucalopride, which works by activating serotonin (5-HT4) receptors in the digestive tract. These receptors help regulate the muscle contractions that move stool through the colon. 

In simple terms, prucalopride stimulates the bowel muscles to contract in a coordinated, wave-like pattern known as peristalsis. This action promotes regular bowel movements without forcing the colon to work unnaturally hard, as some stimulant laxatives do. 

Clinically, this mechanism matters because many people with chronic idiopathic constipation have sluggish or uncoordinated colon movement. By enhancing natural motility rather than merely softening stool, Motegrity addresses one of the root causes of chronic constipation. 

Unlike older 5-HT4 agonists, prucalopride is highly selective, meaning it primarily acts in the gut and has a lower risk of cardiovascular side effects, which were a concern with earlier drugs in this class (NIH, 2023). 

Motegrity side effects 

While Motegrity is generally well tolerated, it can cause side effects in some patients. Most are mild and temporary, especially during the first few days of treatment as the body adjusts. 

Common side effects include: 

  • Headache 
     
  • Nausea 
     
  • Abdominal pain or cramps 
     
  • Diarrhea 
     
  • Dizziness or fatigue 

Less common but potentially serious side effects may include: 

  • Mood changes or new or worsening depression 
     
  • Suicidal thoughts (rare but reported) 
     
  • Allergic reactions such as swelling, rash, or difficulty breathing 

Patients and caregivers should monitor for any mood or behavioral changes, especially early in treatment. Those with a history of depression or suicidal thoughts should inform their doctor before starting Motegrity. 

Seek immediate medical attention if you experience symptoms of a severe allergic reaction or unusual mood changes. 

Avoid Motegrity if you have: intestinal perforation or obstruction, severe inflammatory digestive conditions (e.g., Crohn’s, ulcerative colitis), or allergies to prucalopride or its inactive ingredients. 

Overall, the majority of patients tolerate Motegrity well, and most side effects lessen with continued use or dose adjustments made under medical supervision. 

Motegrity dosage 

Motegrity is a daily oral tablet, taken with or without food, for long-term use. Dosage is based on age, kidney function, and health, with lower doses potentially needed for severe kidney impairment. Consistent daily use is crucial for effectiveness. 

Follow-up visits assess bowel movement frequency/consistency, monitor side effects/emotional well-being, and adjust dosage.  

Older adults and those with kidney issues should use Motegrity cautiously due to kidney clearance. If a dose is missed, take it when remembered, unless it’s near the next dose to avoid doubling. 

Does Motegrity have a generic version? 

As of 2025, no generic version of Motegrity (prucalopride) is available in the United States. It remains a brand-name medication manufactured by Takeda Pharmaceuticals. However, international versions may exist in other markets. 

Generic prucalopride exists in Europe and Canada. Once an FDA-approved generic is available in the U.S., it will be safe, effective, bioequivalent, and cheaper. For affordability concerns, patients can explore savings programs with their healthcare provider or pharmacist. 

Conclusion 

Motegrity (prucalopride) offers a modern, targeted solution for adults struggling with chronic idiopathic constipation, a condition that can significantly impact daily comfort and quality of life. By gently stimulating the natural muscle activity of the colon, it helps restore regular, predictable bowel movements without relying on harsh stimulant laxatives. 

While side effects like headache or nausea can occur, most are manageable, and serious risks are rare with proper use. Each patient’s experience is unique. Discuss symptoms, mental health history, and other medications with your doctor before starting Motegrity. Under medical supervision, Motegrity can provide lasting relief, improve digestive health, and enhance well-being. 

References 

  1. U.S. Food and Drug Administration (FDA). (2018). FDA approves Motegrity (prucalopride) for chronic idiopathic constipation in adults. Retrieved from https://www.fda.gov 
     
  1. Mayo Clinic. (2024). Prucalopride (oral route) description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Prucalopride: Drug information. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2023). 5-HT4 receptor agonists and gastrointestinal motility. Retrieved from https://www.nih.gov 

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Brand Information

MOTEGRITY (PRUCALOPRIDE)
1INDICATIONS AND USAGE
MOTEGRITY
2DOSAGE AND ADMINISTRATION
MOTEGRITY can be taken with or without food. The recommended dosage by patient population is shown in Table 1.
3DOSAGE FORMS AND STRENGTHS
MOTEGRITY Tablets:
  • 1 mg prucalopride: White to off-white, round, biconvex film-coated tablet debossed with "PRU 1" on one side and no debossing on the other side.
  • 2 mg prucalopride: Pink, round, biconvex film-coated tablet debossed with "PRU 2" on one side and no debossing on the other side.
4CONTRAINDICATIONS
MOTEGRITY is contraindicated in patients with:
  • A history of hypersensitivity to MOTEGRITY. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum.
5OVERDOSAGE
An overdose may result in appearance of symptoms from an exaggeration of the known pharmacodynamic effects of prucalopride and includes headache, nausea, and diarrhea. Specific treatment is not available for MOTEGRITY overdose. Should an overdose occur, treat symptomatically and institute supportive measures, as required. Extensive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.
6DESCRIPTION
MOTEGRITY (prucalopride) tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT
The molecular formula is C
Chemical Structure
Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9.
Each 1-mg film-coated tablet of MOTEGRITY contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, and triacetin.
Each 2-mg film-coated tablet of MOTEGRITY contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2.
7CLINICAL STUDIES
The efficacy of MOTEGRITY for the treatment of CIC was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical trials in 2,484 adult patients (Studies 1 to 6;
Eligible patients required a history of chronic constipation defined as having fewer than 3 spontaneous bowel movements (SBMs) per week that resulted in a feeling of complete evacuation (complete, spontaneous bowel movement [CSBM]) and 1 or more of the following symptoms for greater than 25% of bowel movements in the preceding 3 months, with symptoms onset more than 6 months prior to screening:
  • Lumpy or hard stools
  • Sensation of incomplete evacuation
  • Straining at defecation
Patients who never had SBMs were eligible. In Study 1, eligibility also included sensation of ano-rectal obstruction or blockade or the need for digital manipulation in more than 25% of bowel movements. In all studies, patients were excluded if constipation was due to secondary causes or suspected to be drug-induced.
Efficacy was assessed using information provided by patients in a daily diary.
8HOW SUPPLIED/STORAGE AND HANDLING
MOTEGRITY tablets containing 1 mg prucalopride are white to off-white, round, biconvex film-coated tablets debossed with "PRU 1" on one side and no debossing on the other side. They are supplied as:
  • NDC 54092-546-01: HDPE bottle of 30 tablets, with child-resistant closure.
MOTEGRITY tablets containing 2 mg prucalopride are pink, round, biconvex film-coated tablets debossed with "PRU 2" on one side and no debossing on the other side. They are supplied as:
  • NDC 54092-547-01: HDPE bottle of 30 tablets, with child-resistant closure.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Suicidal Ideation and Behavior: Inform patients, their caregivers, and family members that suicidal ideation and behavior, self-injurious ideation as well as new onset or worsening depression have been reported in patients treated with MOTEGRITY. Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior. Instruct patients, caregivers, and family members to discontinue MOTEGRITY immediately and contact their healthcare provider if any of these symptoms occur [see .
  • Pregnancy: Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to MOTEGRITY during pregnancy
10PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
Rx Only
motegrity
1 mg
Usual Dose: One tablet once daily.
PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
11PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label
Rx Only
motegrity
2 mg
Usual Dose: One tablet once daily.
PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label